← FDA Drug Approvals (Drugs@FDA)
ISOTRETINOIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2026-09-10
Drug application
- FDA Application #
ANDA220336- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ISOTRETINOIN
- Generic name
- Isotretinoin
- Active ingredients
- ISOTRETINOIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AUROBINDO PHARMA LTD
- First approval
- 2026-09-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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